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Author Interviews, Heart Disease, JAMA, Lipids / 03.07.2024

MedicalResearch.com Interview with: Evan A Stein MD PhD FACC COO/CSO LIB Therapeutics Cincinnati. OH USA 45227 MedicalResearch.com: What is the background for this study? Response: Cardiovascular disease (CVD) remains the main cause of morbidity and mortality worldwide and is increasing in rapidly industrializing countries and is projected to cause more than >20 million deaths annually over the next 15 years. Low-density lipoprotein cholesterol (LDL-C) is well established as a major, easily modifiable, risk factor for CVD. Reductions with statins and, more recently, PCSK9 inhibitors, all agents which directly or indirectly upregulate the LDL receptor and enhance LDL-C clearance, have demonstrated CVD event reductions in cardiovascular outcome trials. Extensive data from these trials, provide a rough estimate that every 40 mg/dL reduction in LDL-C will reduce the risk of major CV cardiovascular events by 22% to 24%. Furthermore, trials with PCSK9 inhibitors added to statins which achieve substantial additional LDL-C reduction show and CVD event reduction remains linear to very low LDL-C levels without signals of adverse events. Based on this body of evidence, recent revisions to national and international guidelines, now advocate for greater LDL-C reductions and lower LDL-C treatment goals, for patients not achieving these goals on statins alone. The current consensus target goal for LDL-C in patients with CVD, or who are at very-high risk for of CVD, is now less than <55 mg/dL, and <70 mg/dL for those at high risk. This global trial of over 900 patients with CVD, or at very or high risk for CVD, on maximally tolerated statins assessed the 52-week efficacy and safety of monthly lerodalcibep. (more…)
Author Interviews, JAMA, Lipids, Pediatrics, USPSTF / 26.07.2023

MedicalResearch.com Interview with: Li Li, M.D., Ph.D., M.P.H Walter M. Seward Professor Chair of Family Medicine Director of population health University of Virginia School of Medicine Editor-in-chief of The BMJ Family Medicine Dr. Li joined the U.S. Preventive Services Task Force in January 2021 MedicalResearch.com: What is the background for this study? What are the main findings? Response: The Task Force reviewed the latest available evidence to evaluate whether screening all children and adolescents who are 20 years old or younger for high cholesterol improves their heart health into adulthood. At this time, there is not enough evidence to determine whether or not screening all kids is beneficial, so we are calling for additional research on the effectiveness of screening and treatment of high cholesterol in kids and teens. (more…)
Author Interviews, Brigham & Women's - Harvard, Heart Disease, JAMA, Lipids / 16.11.2021

MedicalResearch.com Interview with: Nicholas A. Marston, MD, MPH Thrombolysis in Myocardial Infarction (TIMI) Study Group Brigham and Women’s Hospital Harvard Medical School Boston, Massachusetts MedicalResearch.com: What is the background for this study? Response: There has been recent debate about how much of lipid-associated cardiovascular risk is from LDL cholesterol versus triglycerides. However, genetic studies suggest that apolipoprotein B is actually the primary driver of atherosclerotic risk. Since there is exactly one apoB lipoprotein on each lipid particle (LDL, IDL, VLDL), its measurement is a surrgate for the total number of apoB-containing lipoproteins. So in this study, we asked the question: Do common measures of cholesterol concentration, triglyceride concentration, or their ratio carry predictive value for cardiovascular risk beyond the number of apo-B containing lipoproteins? (more…)
Author Interviews, COVID -19 Coronavirus, Dermatology, Lancet / 17.03.2021

MedicalResearch.com Interview with: Matt Spick, Post-Graduate Researcher University of Surrey Faculty of Engineering and Physical Sciences Guildford, UK MedicalResearch.com: What is the background for this study? Are you measuring lipids or the virus? Response: In this study, we aimed to detect what the virus does to us, rather than the virus itself. The gold standard for detecting COVID-19 is the RT-PCR test, but by their nature, PCR tests only provide diagnostic information, and at times during the pandemic the availability of PCR tests has been a bottleneck for the identification of the disease. Our goal was to investigate a novel method for the diagnosis of COVID-19, at the same time as learning more about what the disease does to us through lipidomics. (more…)
AHA Journals, Author Interviews, Genetic Research, Heart Disease / 08.03.2021

MedicalResearch.com Interview with: Giordano Bottà, PhD CEO and Co-founder Allelica The Polygenic Risk Score Company MedicalResearch.com: What is the background for this study? Response: Previous research identified that polygenic risk score (PRS) has the highest predictive power compared to other risk factors and identifies individuals with the same risk of those with familial hypercholesterolemia, but are invisible to traditional risk assessment. We explored for the first time the interplay between the main causes of atherosclerosis, LDL cholesterol and PRS.  We were interested in helping cardiologists understand why some individuals have bad arteries full of plaques while others don't in presence of the same LDL levels and no additional risk factors. Our findings explain why this is the case: LDL does not affect everyone the same. We believe that we are at the forefront of a change of paradigm in cardiovascular risk assessment: LDL levels cannot be accessed without considering the genetics of an individual. (more…)
Aging, Author Interviews, Geriatrics, Heart Disease, Lancet, Lipids / 11.11.2020

MedicalResearch.com Interview with: Børge G. Nordestgaard, MD, DMSc Professor, University of Copenhagen Chief Physician, Dept. Clinical Biochemistry Herlev and Gentofte Hospital Copenhagen University Hospital Herlev, Denmark  MedicalResearch.com: What is the background for this study? Response: Previous studies have yielded mixed results regarding the association between elevated cholesterol levels and increased risk of atherosclerotic cardiovascular disease in individuals above age 70 years; with some studies showing no association and others only minimal association. However, these previous studies were based on cohorts recruiting individuals decades ago where life-expectancy were shorter and where treatment of comorbidities were very different from today (more…)
Author Interviews, Heart Disease, Lipids, PAD, Women's Heart Health / 27.08.2020

MedicalResearch.com Interview with: First Author: Dhruv Mahtta, DO, MBA Cardiovascular Disease Fellow Baylor College of Medicine Houston, TX Senior & Corresponding Author Dr. Virani Salim S. Virani, MD, PhD, FACC, FAHA, FASPC Professor, Section of Cardiovascular Research Director, Cardiology Fellowship Training Program Baylor College of Medicine Staff Cardiologist, Michael E. DeBakey Veterans Affairs Medical Center Co-Director, VA Advanced Fellowship in Health Services Research & Development at the Michael E. DeBakey VA Medical Center, Houston, TX Investigator, Health Policy, Quality and Informatics Program Michael E. DeBakey Veterans Affairs Medical Center HSR&D Center of Innovation Houston, TX @virani_md MedicalResearch.com: What is the background for this study? What are the main findings? What do you think accounts for the gender differences? Response: We know that women with ischemic heart disease (IHD) have lower prescription rates for statin and high-intensity statin therapy. In this study, we assessed whether the same trends hold true for women with other forms of atherosclerotic cardiovascular disease (ASCVD) i.e. women with peripheral artery disease (PAD) or ischemic cerebrovascular disease (ICVD). Maximally tolerated statin therapy is a Class-I indication in patients with clinical ASCVD which includes PAD and ICVD. We also assessed statin adherence among men and women with PAD and ICVD. Lastly, we performed exploratory analyses to assess whether statin therapy, statin intensity, and statin adherence in women with PAD and ICVD were associated with cardiovascular outcomes and/or mortality.  (more…)
Author Interviews, Lipids, Regeneron / 26.08.2020

MedicalResearch.com Interview with: Professor F. J. Raal, FRCP, FCP(SA), Cert Endo, MMED, PhD Director, Carbohydrate & Lipid Metabolism Research Unit Professor & Head, Division of Endocrinology & Metabolism, Faculty of Health Sciences, University of the Witwatersrand  MedicalResearch.com: What is the background for this study? Response: The objective of this randomized phase 3 study was to evaluate the efficacy and safety of evinacumab in adult patients with homozygous familial hypercholesterolemia (HoFH), a condition that remains very difficult to treat. The primary endpoint was reduction of low-density lipoprotein cholesterol (LDL-C) from baseline with evinacumab compared to placebo at 24 weeks.  MedicalResearch.com: Would you briefly explain what is meant by homozygous familial hypercholesterolemia? How many individuals may be affected by this disorder? Response: HoFH, or homozygous familial hypercholesterolemia, is the most serious and more rare form of familial hypercholesterolemia (FH).  It is estimated that as many as 1 in 300,000 people worldwide and approximately 1,300 people in the U.S. are affected by HoFH. A person who has HoFH has inherited two FH genes, one from each parent. They therefore have LDL-C levels that are elevated 4-fold or greater from birth and are at high risk for premature atherosclerotic disease and cardiac events which can occur in childhood. While current treatment guidelines recommend early and intensive LDL-C lowering, people with HoFH tend to be less responsive (or unresponsive) to standard lipid-lowering therapies, including high-intensity statins and PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors and often require lipid apheresis. (more…)
Author Interviews, Heart Disease, JAMA, Lipids / 21.08.2020

MedicalResearch.com Interview with: First Author Dhruv Mahtta, DO, MBA Cardiovascular Disease Fellow Baylor College of Medicine Houston, TX Senior & Corresponding Author Salim S. Virani, MD, PhD, FACC, FAHA, FASPC Professor, Section of Cardiovascular Research Director, Cardiology Fellowship Training Program Baylor College of Medicine Staff Cardiologist, Michael E. DeBakey Veterans Affairs Medical Center Co-Director, VA Advanced Fellowship in Health Services Research & Development Michael E. DeBakey VA Medical Center, Houston, TX MedicalResearch.com: What is the background for this study? Response: The incidence of atherosclerotic cardiovascular disease among young patients has been on the rise. These patients with premature and extremely premature atherosclerotic cardiovascular disease experience similar rates of mortality compared to older adults. Additionally, these young patients have a greater accrued rate of life-time morbidity. Therefore, secondary prevention measures such as use of guideline concordant statin therapy and aspirin therapy are paramount in this population.  (more…)
Author Interviews, Heart Disease, JAMA, Lipids, Metabolic Syndrome, UCSF / 12.08.2020

MedicalResearch.com Interview with: Prakash Deedwania, MD, FACC,FAHA,FASH,FHFSA,FESC Professor of Medicine, UCSF School of Medicine, San Francisco MedicalResearch.com: What is the background for this study? What are the main findings? Response: This paper describes the findings form the FOURIER study, a very large study evaluating the efficacy of evolocumab, a PCSK9 inhibitor in patients with metabolic syndrome and preexisting atherosclerotic cardiovascular disease (ASCVD) who were already being treated with statins. In this largest study of its kind of 27,000 patients we found that 60% of patients with ASCVD had metabolic syndrome. We also found that the presence of metabolic syndrome identified a higher risk of future cardiac & coronary events in these patients despite them receiving maximum tolerated doses of statin. Furthermore, study treatment with evolocumab was efficacious in reducing the increased risk during the median follow up of nearly 3 years . Unlike treatment with statins there was no risk of new-onset diabetes with evolocumab, which was generally well tolerated. What was interesting thatpatients without metabolic syndrome had much less benefit with PCSK9 inhibition. These findings suggest that the presence of metabolic syndrome can help the clinicians identify the ASCVD patients who are most likely to benefit from treatment with PCSK9 inhibitors. This will be of great help for the cost containment of therapeutic strategy as PCSK9 inhibitors as a class are still quite expensive drugs. (more…)
Alzheimer's - Dementia, Author Interviews, Cognitive Issues, JAMA, Lipids / 14.07.2020

MedicalResearch.com Interview with: Manja Koch, Ph.D., Research Associate Department of Nutrition Harvard T.H. Chan School of Public Health Majken K. Jensen, Ph.D. Adjunct Professor of Nutrition Harvard T.H. Chan School of Public Health & Professor in the Department of Public Health University of Copenhagen, Copenhagen, Denmark     MedicalResearch.com: What is the background for this study? Response: Alzheimer’s disease and other dementias are highly prevalent conditions. According to the Alzheimer’s Association, 50 million people are currently living with Alzheimer’s disease or other dementias worldwide. Lower apolipoprotein E in plasma is a risk factor for dementia, but the underlying biological mechanisms are not fully understood. Thus, we investigated the role of apolipoprotein E overall and in lipoproteins with distinct metabolic functions in relation to cognitive function and dementia risk.. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Heart Disease, Race/Ethnic Diversity, Statins / 14.05.2020

MedicalResearch.com Interview with: Dr. Ankur Pandya, PhD Assistant Professor of Health Decision Science Department of Health Policy and Management Harvard T.H. Chan School of Public Health MedicalResearch.com: What is the background for this study? Response: The 2013 ACC-AHA cholesterol treatment guidelines greatly expanded statin medication eligibility for individuals between the ages of 40-75 years without known cardiovascular disease, and there was some concern that African Americans at "intermediate risk" per those guidelines could be (arguably) overtreated with statins. The 2018 ACC-AHA guidelines included coronary artery calcium assessment for individuals at intermediate cardiovascular disease risk; those with a "zero" calcium score and no other risk factors would now change the eligibility (from indicated statin to not indicated). (more…)
Author Interviews, Heart Disease, Lipids / 02.04.2020

MedicalResearch.com Interview with: Nathan D. Wong, PhD, FACC, FAHA, FNLA Professor and Director Heart Disease Prevention Program Division of Cardiology, University of California, Irvine MedicalResearch.com: What is the background for this study? Response: Many higher risk persons, despite guideline-recommended therapy such as statins, still suffer from cardiovascular disease events. There are few therapies available to reduce this persistent risk. The REDUCE-IT trial led by Brigham and Women’s Hospital in Boston researchers originally published in November of 2018 was landmark in showing for the first time a highly purified, stable, prescription fish oil product, icosapent ethyl (an EPA only compound marketed as Vascepa®) if given to high risk persons with either cardiovascular disease or diabetes and two or more risk factors who were on statin therapy and had elevated triglyceride levels, achieved an unprecedented 25 percent reduction in the risk of time to first cardiovascular disease events. Given that many persons often experience multiple cardiovascular events, a follow-up analysis showed that TOTAL cardiovascular events were reduced by 30 percent.  (more…)
Author Interviews, Heart Disease, Lipids / 01.04.2020

MedicalResearch.com Interview with: Professor F. J. Raal, FRCP, FCP(SA), Cert Endo, MMED, PhD Director, Carbohydrate & Lipid Metabolism Research Unit Professor & Head, Division of Endocrinology & Metabolism, Faculty of Health Sciences, University of the Witwatersrand MedicalResearch.com: What is the background for this study? How does Evinacumab differ from the three drugs used in triple therapy for this severe form of hypercholesterolemia? Response:      Despite available lipid lowering therapies, the vast majority of patients with homozygous familial hypercholesterolemia are unable to achieve desirable LDL-cholesterol levels and remain at high risk for premature atherosclerotic cardiovascular disease. Unlike statins and PCSK9-inhibitors which act mainly by upregulating LDL receptor activity on the cell surface, evinacumab, a monoclonal antibody inhibitor of ANGPTL3, acts independent of the LDL receptor. (more…)
Author Interviews, Lipids, NEJM, Neurological Disorders, Stroke / 18.11.2019

MedicalResearch.com Interview with: Pierre Amarenco, MD Professor and Chairman Paris University, Paris, France INSERM Department of Neurology and Stroke Centre Bichat Hospital Paris, France MedicalResearch.com: What is the background for this study? Response: The rationale of the Treat Stroke to target trial was that after we published the SPARCL trial in 2006 (atorvastatin 80 mg/day vs placebo in patients with stroke) which showed a 16% relative risk reduction of recurrent stroke, we performed several pre specified and post hoc analyses, showing that in SPARCL patients randomized with "atherosclerotic disease" the risk reduction for the primary endpoint was much higher (33%), and in in patients achieving a LDL cholesterol of less than 70 mg/dL as compared to those achieving a LDL cholesterol 100 mg/dL or higher, the risk reduction was 28%. Therefore to confirm this findings, we designed the TST trial, which was an investigator initiated trial funded by the french ministry of health,  and enrolled patients with an ischemic stroke due to atherosclerotic stenosis and randomized them to either a target LDL cholesterol of less than 70 mg/dL or a target LDL cholesterol of 90 to 110 mg/dL. To achieve these goals, the investigators could use any statin available on the market, and titrate the dosage of the statin to get to the assigned target. They could also use ezetimibe on top of statin therapy if a high dosage of statin was not sufficient to get to the target level assigned by randomization. (more…)
AHA Journals, Author Interviews, Heart Disease, Lipids / 17.09.2019

MedicalResearch.com Interview with: Samuel S. Gidding, MD FH Foundation Pasadena, CA MedicalResearch.com: What is the background for this study? Response: Patients with familial hypercholesterolemia are at high risk for atherosclerotic heart disease but little is known about intensification of treatment and event rates in lipid specialty care in the United States. We examined data on 1900 patients, enrolled in the CASCADE FH Registry,sponsored by the Familial Hypercholesterolemia Foundation, to determine if cholesterol lowering therapy increased to improve getting patients to a lower LDL cholesterol and to look at incident cardiac events in tow groups, those with prior heart disease and those without. (more…)
Author Interviews, Heart Disease, Lipids / 18.07.2019

MedicalResearch.com Interview with: Guanmin Chen MD PhD MPH Senior Biostatistician Research Facilitation, Alberta Health Services Adjunct Research Assistant Professor University of Calgary  Co-authors: Guanmin Chen, PhD, MD, MPH, Megan S. Farris, MSc, Tara Cowling, MA, MSc, Stephen M. Colgan, PhD, Pin Xiang, PharmD, Louisa Pericleous, PhD, Raina M. Rogoza, MSc, Ming-Hui Tai, MSc, PhD, and Todd Anderson, MD  MedicalResearch.com: What are the main findings? Response:
  • Atherosclerotic cardiovascular disease (ASCVD) remains a significant cause of morbidity and mortality in Canada (and worldwide). Despite the established benefits of treatment with statins, most Canadians fail to achieve dyslipidemia targets (a risk factor for ASCVD).
  • The objective of this study was to examine current treatment patterns of lipid-lowering therapies for the management of low-density lipoprotein cholesterol (LDL-C) in patients with ASCVD.
  • This was a retrospective cohort study conducted using province-wide administrative health data from Alberta, Canada. Datasets used included health services, pharmaceutical, and laboratory data, in addition to the Alberta population registry. The study population consisted of individuals aged 18 years or older diagnosed with ASCVD between 2011-2015, based on International Classification of Diseases (ICD) codes. The cohort was then restricted to individuals with an initial (index) LDL-C measurement after ASCVD diagnosis and at least one year of pre-index data and one year of follow-up data.
(more…)
Amgen, Author Interviews, Cost of Health Care, JAMA, Lipids, UCLA / 24.06.2019

MedicalResearch.com Interview with: Gregg C. Fonarow, MD, FACC, FAHA Eliot Corday Professor of Cardiovascular Medicine and Science Director, Ahmanson-UCLA Cardiomyopathy Center Co-Chief of Clinical Cardiology, UCLA Division of Cardiology Co-Director, UCLA Preventative Cardiology Program David Geffen School of Medicine at UCLA Los Angeles, CA  MedicalResearch.com: What is the background for this study? Response: Last year, Amgen made the PCSK-9 inhibitor evolocumab available at a reduced list price of $5,850 per year This 60% reduction was aimed at improving patient access by lowering patient copays, especially for Medicare beneficiaries. Additionally, the treatment landscape for PCSK9 inhibitors was further defined in 2018 when the American College of Cardiology/American Heart Association Multisociety Clinical Guideline on the Management of Blood Cholesterol recommended PCSK9 inhibitors for, among other patient populations, patients with very high-risk (VHR) ASCVD whose low-density lipoprotein cholesterol levels remain at 70 mg/dL or more  despite a heart-healthy lifestyle and treatment with standard background therapy. (more…)
Author Interviews, Clots - Coagulation, Duke, Genetic Research, Heart Disease, JAMA / 30.05.2019

MedicalResearch.com Interview with: Thomas J. Povsic, MD, PhD Interventional Cardiologist Duke Clinical Research Institute Duke University School of Medicine Durham, North Carolina  MedicalResearch.com: What is the background for this study?  Response: The background for this study is that it is unknown how mandatory reporting of CYP2C19 metabolizer status affects how doctors treat patients or to what degree provision of this information would affect choice of a P2Y12 inhibitor within a clinical trial. As part of the GEMINI-ACS trial, all patients underwent CYP2C19 metabolizer testing.  This trial enrolled patients with a recent acute coronary syndrome and randomized them to aspirin or a low dose of rivaroxaban.  All patients were also to be treated with ticagrelor or clopidogrel, which was at the discretion of the investigator.  Investigators were given information regarding the CYP2C19 metabolizer status about a week after randomization.  Importantly prior to randomization, all investigators were asked how they expected to use this information, and then we followed what they actually did. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Lipids / 28.05.2019

MedicalResearch.com Interview with: Samia Mora, MD, MHS Associate Physician, Brigham and Women's Hospital Associate Professor of Medicine, Harvard Medical School Brigham and Women's Hospital Department of Medicine Preventive Medicine Boston, MA 02115  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Lipid testing plays a major role in cardiovascular disease (CVD) risk screening, prediction, and treatment. In the past decade, several pivotal studies (including the Women’s Health Study, the Copenhagen City Heart Study, and the Copenhagen General Population Study) compared populations of individuals who had fasting lipid testing with populations of individuals who had nonfasting lipid testing, and found that non-fasting lipids were at least as good as fasting lipids in cardiovascular risk screening and predicting CVD risk. To date, however, no study has examined the cardiovascular predictive value of lipids measured on the same individuals who had both fasting and nonfasting lipid testing. This is important because individual-level variability in fasting versus nonfasting lipids may not be captured when looking at population-level risk associations, and evidence from randomized studies is lacking. Furthermore, it is unclear whether substituting nonfasting lipids would misclassify cardiovascular risk for individuals who may be eligible for statin therapy. (more…)
Author Interviews, JAMA, Lipids, Pediatrics / 22.05.2019

MedicalResearch.com Interview with: Amanda Marma Perak, MD, MS Assistant Professor of Pediatrics (Cardiology) and Preventive Medicine MedicalResearch.com: What is the background for this study? Response: Blood cholesterol is a critical initiator of atherosclerotic plaques in the arteries that can lead to heart attack in adulthood. It is well established that these changes in the blood vessels occur already in childhood. Thus, it is important to know the status of cholesterol levels in youth to inform public health efforts aimed at preventing cardiovascular disease in the population. In the US there have been changes in childhood obesity prevalence (which may worsen cholesterol levels), the food supply (such as reduction of trans fats which may improve cholesterol levels), and other factors in recent years. We therefore designed a study to examine trends in cholesterol levels among youth in recent years. (more…)
Author Interviews, C. difficile, Gastrointestinal Disease, Johns Hopkins, Lipids / 09.05.2019

MedicalResearch.com Interview with: Rajesh Kumar NV, Ph.D. Affiliation during the study: Senior Manager, Human Therapeutics Division, Intrexon Corporation, Germantown, MD, USA Current affiliation: Translational Research Program Manager, Oncology Drug Discovery, Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine Baltimore, MD,   MedicalResearch.com: What is the background for this study? Response: Clostridium difficile is a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon. Clostridium difficile infection is the most frequent form of colitis in hospitals and nursing homes and affects millions of patients in the United States and abroad. Clostridium difficile associated disease (CDAD) is a global public health challenge where even mild to moderate infections at times can quickly progress to a fatal disease if not treated promptly. OG253 is a novel lantibiotic in development for the treatment of CDAD. Lantibiotics are antimicrobial peptides whose chemical structure includes a bridge maintained by the non-canonical amino acid lanthionine. The primary objective of our study was to evaluate the repeated dose toxicokinetics and any possible side effects of OG253 as enteric-coated capsules following daily oral administrations of three different doses (6.75, 27 and 108 mg/day) for a single day or seven consecutive days in both genders of rats. An enteric-coated capsule of OG253 was formulated in an attempt to circumvent the proteolytic degradation of OG253 in the upper digestive tract and specifically deliver this lantibiotic to the distal portion of the small intestine. (more…)
Author Interviews, Genetic Research, Heart Disease, JAMA, Lipids / 25.04.2019

MedicalResearch.com Interview with: Florian Kronenberg, MD Division of Genetic Epidemiology Department of Medical Genetics, Molecular and Clinical Pharmacology Medical University of Innsbruck, Innsbruck, Austria MedicalResearch.com: What is the background for this study? Response: Lp(a) is one of the most prevalent lipoprotein risk factors for cardiovascular disease. Roughly 20% of the general Caucasian population have concentrations above 50 mg/dL and the 10% with the highest concentrations have a 2 to 3-fold increased risk for myocardial infarction. There is strong evidence from genetic studies that high Lp(a) concentrations are causally related to cardiovascular outcomes. Until recently there was no drug available which lowers Lp(a) without any effects on other lipoproteins. This has recently changed by the development of drugs that block the production of Lp(a) in an impressive way. These drugs have to be studied in randomized controlled trials whether they not only lower Lp(a) concentrations but also cardiovascular outcomes. For the planning of such studies it is crucial to estimate the amount of Lp(a) lowering required to show a clinical benefit. (more…)
Accidents & Violence, Author Interviews, Heart Disease, Inflammation, JACC, Lipids / 18.03.2019

MedicalResearch.com Interview with: Dr. George Dangas MD PhD Professor of Medicine, Cardiology Mount Sinai Health System MedicalResearch.com: What is the background for this study? Response: Widespread use of statins targeted to decrease levels of low density lipoprotein cholesterol (LDL-C) below 70mg/dL are recommended by guidelines. However, residual cholesterol risk may only be one part of the residual risk equation. Indeed, Biological inflammation has long been known as a pathophysiological mechanism of atherosclerosis and the recent CANTOS trial opened new therapeutic perspective by demonstrating that inflammation modulation via selective interleukin-1β inhibition could result in improved diagnosis in patients with coronary artery disease. However, the prevalence and impact of a residual inflammatory biological syndrome in patients with controlled cholesterol risk is unclear. (more…)
Author Interviews, Genetic Research, Heart Disease, Lipids, NEJM, Statins / 13.03.2019

MedicalResearch.com Interview with: Brian A Ference, MD, MPhil, MSc, FACC, FESC Professor and Director of Research in Translational Therapeutics Executive Director, Centre for Naturally Randomized Trials Strangeways Research Laboratory University of Cambridge Cambridge, UK MedicalResearch.com: What is the background for this study? Response: Bempedoic acid is a novel therapy currently in development that lowers LDL-C by inhibiting ATP-citrate lyase, an enzyme in the same cholesterol biosynthesis pathway as HMG-CoA reductase (the target of stains).  However, whether lowering LDL-C by inhibiting ATP-citrate lyase will reduce the risk of cardiovascular events to the same extent as lowering LDL-C by inhibiting HMG-CoA reductase with a statin is unknown. We conducted a “naturally randomized trial” using Mendelian randomization in more than 650,000 participants who experienced more than 100,000 cardiovascular events to evaluate the potential clinical benefit of lowering LDL-C by inhibiting ATP-citrate lyase as compared to lowering LDL-C by inhibiting HMG-CoA reductase. (more…)
Author Interviews, Heart Disease, Imperial College, Lipids, NEJM, Statins / 13.03.2019

MedicalResearch.com Interview with: Prof. Kosh Ray, MB ChB, MD, MPhil Faculty of Medicine, School of Public Health Chair in Public Health (Clinical) Imperial College London MedicalResearch.com: What is the background for this study? What are the main findings? Response: Bempedoic acid is the first in class of a new therapy for lowering LDL cholesterol. This is the largest and longest study to date with this therapy and involved about 2200 pts with patients with either established cardiovascular disease or familial hypercholestrolaemia and in whom LDL was > 70mg/dl or 1.8 mmol/L despite maximally tolerated statins. %0% were on high intensity statins and the majority of the rest on moderate intensity. The aim was to show long term safety 1 year and efficacy at 24 weeks and at 1 year.  (more…)